Difference between revisions of "Encorafenib (Braftovi)"
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2018-09-19: Iniital authorization | *2018-09-19: Iniital authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2021-03-02: Initial notice of compliance for use in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test. | ||
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==Also known as== | ==Also known as== | ||
*'''Code name:''' LGX818 | *'''Code name:''' LGX818 | ||
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[[Category:EMA approved in 2018]] | [[Category:EMA approved in 2018]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
Revision as of 00:15, 10 May 2023
General information
Class/mechanism (from NCI Drug Dictionary): An orally available Raf kinase inhibitor with potential antineoplastic activity. LGX818 specifically inhibits Raf kinase, a serine/threonine enzyme in the RAF/mitogen-activated protein kinase kinase (MEK)/extracellular signal-related kinase (ERK) signaling pathway.
Diseases for which it is used
History of changes in FDA indication
- 2018-06-27: Initial FDA approval in combination with Binimetinib (Mektovi) for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. (Based on COLUMBUS)
- 2020-04-09: Approved in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. (Based on BEACON CRC)
History of changes in EMA indication
- 2018-09-19: Iniital authorization
History of changes in Health Canada indication
- 2021-03-02: Initial notice of compliance for use in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.
Also known as
- Code name: LGX818
- Brand name: Braftovi